Precision Surgery for Pediatric Hydrocephalus: VPS vs. ETV With ML-Guided Prediction
NCT ID: NCT07330206
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
800 participants
OBSERVATIONAL
2016-01-01
2024-01-20
Brief Summary
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Main questions
* Does ETV produce higher 6-month surgical success and lower 2-year re-intervention rates than VPS in prespecified subgroups (age ≥3 y, obstructive hydrocephalus, normal basal cisterns)?
* Does a machine-learning model (ETV-PS) using pre-operative MRI features accurately predict ETV success (AUC ≥0.80) and thereby reduce unnecessary re-operations?
* Does early, frequent programmable-valve pressure adjustment after VPS decrease over-shunting headaches and improve 2-year cognitive scores compared with standard, infrequent adjustment?
Comparison: ETV group vs. VPS group (1:1 propensity-matched); within VPS cohort, frequent (≥3 adjustments in first 6 mo) vs. infrequent (\<3) pressure-tuning arms.
Participants will
* Provide pre-operative clinical data and MRI/CT imaging.
* Undergo either VPS or ETV as clinically indicated; 320 VPS recipients receive programmable valves with protocol-driven pressure logs.
* Return for standardized neurodevelopmental testing Children's Memory Scale (CMS), Wechsler Intelligence Scale for Children(WISC), Pediatric Quality of Life Inventory(PedsQL) and imaging at 6 mo, 1 y and 2 y; valve adjustments tracked electronically.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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ETV group
All undergo endoscopic third ventriculostomy as initial treatment
MRI-Guided Precision Shunt or ETV Strategy
VPS group
* 320 receive a programmable valve with protocol-driven pressure adjustments
* 80 receive a fixed-pressure valve (included only in VPS-vs-ETV comparisons, excluded from valve-management sub-analysis)
MRI-Guided Precision Shunt or ETV Strategy
Interventions
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MRI-Guided Precision Shunt or ETV Strategy
Eligibility Criteria
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Inclusion Criteria
* Congenital hydrocephalus confirmed by clinical and MRI/CT findings
* First surgical treatment: either VPS or ETV
* Complete pre-operative MRI/CT and ≥ 2-year follow-up data available
Exclusion Criteria
* Severe comorbidities affecting neuro-developmental assessment (e.g., major congenital heart disease, genetic-metabolic disorders)
* Incomplete baseline imaging or follow-up \< 2 years
17 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Zhigang Lan
Professor
Locations
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West China Hospital of Sichuan University
Chengdu, Sichuan, China
Countries
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Other Identifiers
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WestChinaH-HX-2025-011
Identifier Type: -
Identifier Source: org_study_id
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